1. Field of the Invention
This invention relates to a process for the stimulation of production of extracellular dermal matrix proteins in human tissue through the simultaneous delivery of ultrasound and electrical energy thereto. In another aspect, a wound is purposefully created in the dermal layer of the skin to stimulate natural healing processes to be followed by delivery of ultrasound and electrical energy to further advance the production of extracellular dermal proteins (biological protein polymers).
2. Background
Electrical stimulation (e-stim) has been used for years in the healing arts and has been applied in many different waveforms and configurations. As with many other modalities and drugs in medicine, its validity is often overshadowed by exaggerated claims. Electrical stimulation has historically fallen into this category, but has always maintained a place in therapy because of its benefits. Transcutaneous electrical nerve stimulation for pain relief and low intensity direct current for bone mending of non-union fractures drew positive attention to e-stim in recent years. Wound healing in general has always been an excellent vehicle for e-stim primarily with decubitus ulcers. Later studies have indicated that e-stim has been widely accepted and provides numerous benefits such as improved blood flow and bacterial growth inhibition. The question involved in the use of e-stim is that of what waveform should be utilized in the treatment of human tissue since in keeping with the Arndt-Schultz Principle, too little stimuli does nothing, the proper amount will evoke the correct response, and too much can have a destructive effect. A number of commercially manufactured portable electrode systems are available to the public for e-stim applications. Typcially, these systems contain electrodes in pads composed of natural or synthetic gums and gels as the materials directly in contact with the skin. The various electrical circuits are attached to the pad and the electrical energy is transmitted first to the pad. Examples of e-stim electrode systems include those described in U.S. Pat. Nos. 5,974,342; 5,776,170; 4,895,154; 4,786,277 and 4,580,570, which patents are incorporated herein by reference.
The use of ultrasound in physical therapy has been widely practiced with a variety of devices which are intended for transmitting either continuous or pulsed ultrasound energy to the body of a patient for the treatment of various maladies. One such system is that disclosed in Barsotti et al, U.S. Pat. No. 4,791,915, said patent also being incorporated by reference herein. However, with standard external ultrasound there are two basic problems. The first is the power displayed on the meter is never the power delivered in tissue. The second problem is beam uniformity. In the absence of a collimated beam pattern the beam pattern converges and creates a hot spot in the middle.
Thus there is presented a need with the application of ultrasound and e-stim for systems which will overcome the art recognized shortcomings of the currently available systems.
In addition, in attempting to maintain a youthful appearance, it is necessary to stimulate the production of collagen III fibers and elastin to achieve an optimal clinical end result of tissue response that is more consistent with normal healthy tissue. Also, in the normal aging process of the skin which tends to convert collagen III fibers to collagen I fibers through cross-linkage and dimer production, the lack of collagen III fibers and elastin results in the inability of the skin to withstand detrimental external irritants over time and skin that is less resilient.
Thus there is presented a need for a process which will effect the production of collagen III fibers and elastin in human tissue.
It is thus an object of the present invention to provide a process for the effective treatment of human tissue which will effect the production of extracellular dermal proteins in human tissue.
Another object of this invention is to provide a process for the treatment of human tissue to as to stimulate the production of the protein collagen.
A further object of this invention is to provide a process whereby there is produced resilient collagen and elastin in human tissue.